Podcast

Serialization Solution: Integrating The Right Coding Equipment

Source: Domino Amjet Inc.

At Interphex 2014, Todd and Todd interview Mark Schaeffer, Pharmaceutical Business Development Manager with Domino North America to discuss the importance of integrating the proper code printing equipment for serialization. With the Drug Quality and Security Act in effect the biggest issues Domino has seen is to integrate a serialized line, it's a pretty complex process. There's software, there's vision systems, there's potential packaging machinery changes, and there's coding equipment.

Todd S: Good morning. This is Todd and Todd, live in New York, Life Science Connect Radio on location, direct from Interphex day two. Todd, we have an exciting guest up next, but I've got to tell you, I'm just continuously blown away by the quality of the guests we've had in this show. I'm learning a lot today.

Todd Y: There's the quality of the guests, there's the quality of the exhibitors, there's the quality of the exhibit hall. This is a first class operation, start to finish, all parts of it.

Todd S: Yes, I'm looking forward to this conversation. Say hello to Mark Schaeffer. He's the Pharmaceutical Business Development Manager with Domino North America. Mark, welcome to the show.

Mark: Thanks, looking forward to being here.

Todd S: We're glad to have you. Thank you for stopping by and joining us. Mark, before we get into a conversation, take a few quick seconds and tell us a little bit about you and your background.

Mark: Sure. I was born and raised in the printing business, and I've been with Domino for just about fourteen years, in the packaging business for about fifteen years. I started as a territory account manager, and now I run the pharmaceutical business for North America.

Todd S: Go up to 10,000 feet and tell us all about Domino North America. What do you do? How do you serve your market?

Mark: Domino North America is a subsidiary of Domino Printing Sciences out of Cambridge, in the UK. We're a manufacture of marking and coding equipment. We serve the pharmaceutical, life sciences, food and beverage sectors globally.

Todd Y: Talk a little bit more about the issues you help your customers address and their problems that you help them solve.

Mark: Well, typically coding issues range anywhere from compliance issues to efficiency issues. There's a lot of things that drive coding. It's, quite often, the tail wagging the dog in our industry. It's a less expensive piece of equipment but quite often can be the deal breaker for shipping product out a door, and certainly regulatory issues, like e-pedigree can drive a big part of our business.

Todd S: I just want to be sure I'm totally clear on the offerings. Walk us through the critical products and solutions you provide your marketplace.

Mark: Domino, we like to say we offer from product to pallet. Everything from a very primary product, we'll put the date code on a bottle, the date code on a label of pills to inner packs, to bundles, to pallet labeling, case labeling. Anywhere a code is required on a product, that's what Domino provides. We provide the equipment that applies the code.

Todd Y: Talk a little bit about serialization. I mean, that's something that's coming up more and more, it's getting more important.

Mark: Sure it is. Well, it's interesting, because as of the end of last year, the federal government passed the Drug Quality and Security Act. For the better part of the past five or six years, they've been drug manufacturers in North America that were struggling with California e-pedigree and various state mandates, and this federal coming, is it going to be delayed? There's been a lot they've been dealing with, and now the federal law's been passed and it's effective and now it's all hands on deck.

Todd S: What role does Domino play in that process?

Mark: Well, we provide the codes on the products. Among other things in the Drug Quality and Security Act, it requires a code on the item level, a code on the aggregated level. We work really closely with the people that manage the software, that integrate the printers into their equipment, handle it. They put together the cartons and they put together the bottles, and we apply the code. It's a small part of serialization overall, but it's the most vital part. Without the code on the product, it's not serialized.

Todd Y: Talk a little bit about the process and the problems that pop up in dealing with the integration piece of it that you were just talking about.

More often than not, people look at coding equipment as an, “Oh, by the way, we'll add that on the end.” The problem with that is the existing coding equipment may not be suitable to do a serialized code, it may not fit in the existing equipment, or the existing packaging equipment may not be stable enough to do a serialized code.

The challenge is to get people to think of coding equipment at the same time they think of the rest of the equipment when they do a serialized integration. Does that make sense?

Todd S: Yes, it makes perfect sense. Why would you do it any other way? If you step back and look at it, of course that's the way you do it.

Mark: You hate to use the term “holistic view,” but you really need to take a holistic view. You really do, yes.

Todd S: Yes, as I said at the top of the show, we're coming to you from Interphex, so what are you showcasing here?

Our products are typically, as a standalone product that doesn't do anything, but when it's integrated into another piece of equipment, that's where it's relevant. Often, people look at our product and they don't understand what it is.

What we've done is we've reached out to a couple of partners that we've worked with, why their labeling systems don't make a design, and we've said, “Let's take some of your equipment, put it in our booth, and integrate our products into it,” so people can see our equipment firsthand, integrated into a piece of equipment and see how it functions and how it's going to look on their packaging line.

Todd Y: Globalization, just about every conversation we have that topic comes up. Where are we with all of that, in terms of serialization?

Mark: Well, it's a great question. There's probably a lot of smarter people than I that can answer that better than I can, but I think with the federal legislation here, it's starting to more align with the European mandates and some of the other global mandates.

From a supplier standpoint, Domino looks at all the mandates around the world, and while they're very similar, there's a lot of differences between them. You may focus on one of those mandates, but you really have to keep an eye on all of them, so that you're capable of doing it because, such as North America, it's not only that you manufacture here, but if you ship to North America, you need to be compliant. You need to consider all those things.

Todd S: Mark, as we said, Domino is exhibiting here, but you are also attending this show and walking around, and I'm sure you're keenly observing what's going on and what you're learning. When you walk out of this event at the end of the week, what will be Mark Schaeffer's key takeaways from Interphex?

Mark: It's very similar to the last Interphex, and that was unique to us, and that is the people that are visiting us and the people we're talking to, they're coming in with distinct projects and distinct discussions in mind. They're coming in, looking for some help, versus window shopping and checking things out. They've got requirements and they need some assistance.

Todd Y: If you had three wishes – I'll make it easier, just one wish – looking at the industry and the issues, what would that be?

Mark: Well, it's a good question. I hadn't really thought about it, but I think it's actually what the federal legislation is delivering. For the better part of the past five or six years that I've been living through this, some people are hoping for delays and some people are thinking there's going to be delays, and it's been very fragmented in how people go forward.

I think the federal legislation is finally taking people and said, “Okay, forget delays. It's fixed requirements and fixed dates,” and now people are saying, “Okay, how do I get from here to there?”

It's the news of, “Hey, it may vanish or it may not happen or it's going to get pushed out.” I think that's behind us. I guess, to a certain extent, the wish has come true. Now, it's getting down to business, because it's still a monstrous task to undertake.

Todd S: Mark, I hate to say it, but we're running low on time. Before we let you go, how can people get in touch with you and where can they learn more about Domino North America?

Mark: Well, they can certainly reach out to us at www.Domino-NA.com. Reach into our website, they can reach out to me. Our number's 1(800) 244-2501.

Todd S: Alright, Mark Schaeffer, Pharmaceutical Business Development Manager with Domino North America, Mark, it was great to have you. Thanks for stopping by and joining us.